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Regulatory Affairs's & QP Blog | Never give up- expertise in Regulatory affairs and Quality Assurance- EU environment
Regulatory Affairs's and QP Blog. Never give up- expertise in Regulatory affairs and Quality Assurance- EU environment. EMA Adopts Clinical Trials Transparency Plan. October 4, 2014. Open files to public. It will apply to clinical reports contained in all applications for centralised marketing authorisations submitted after that date. The reports will be released as soon as a decision on the application has been taken. For now, EMA said it will publish the following information:. Module 5 (clinical study...
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